$MLYS News
Last published 3d ago
- 3d agoMLYSMineralys Therapeutics Presents New Late-Breaking Data from Transform-HTN Open-Label Extension Trial of Lorundrostat in Hypertension at AHA Scientific Sessions 2026GlobeNewswire– In the largest long-term hypertension trial of an aldosterone synthase inhibitor to date, lorundrostat demonstrated sustained reduction in automated office systolic blood pressure (AOSBP) of 17.8 mmHg at Week 48 from
- 3d agoMLYSMineralys Therapeutics Presents New Late-Breaking Data from Transform-HTN Open-Label Extension Trial of Lorundrostat in Hypertension at AHA Scientific Sessions 2026GlobeNewswire– In the largest long-term hypertension trial of an aldosterone synthase inhibitor to date, lorundrostat demonstrated sustained reduction in automated...
- 5d agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Nov. 06, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines...
- 5d agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Nov. 06, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in
- 1w agoMLYSMineralys Therapeutics, Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 5.02 Item 9.01
- 1w agoMLYSMineralys Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswire– Commercialization plans for lorundrostat are on track ahead of PDUFA target date of December 22, 2026 – – New analyses from the pivotal Launch-HTN trial showed 46% of participants with uncontrolled or resistant
- 1w agoMLYSMineralys Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireRADNOR, Pa., Nov. 03, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes
- 2w agoMLYSMineralys Therapeutics to Announce Third Quarter 2026 Financial Results and Host Conference Call on Wednesday, November 4, 2026GlobeNewswireRADNOR, Pa., Oct. 28, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in
- 2w agoMLYSMineralys Therapeutics Announces Publication of Phase 2 Explore-CKD Trial Results for Lorundrostat in Kidney InternationalGlobeNewswire- Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily added to an SGLT2 inhibitor achieved a statistically significant reduction in systolic blood pressure at four weeks - - New hormonal and urinary
- 2w agoMLYSMineralys Therapeutics Presents New Lorundrostat Data in Participants with Hypertension and Chronic Kidney Disease at ASN Kidney Week 2026GlobeNewswireIn the large, pivotal Phase 3 Launch-HTN trial, lorundrostat achieved similar significant blood pressure reductions in participants with and without CKD, with consistent reductions across Stages 1-3 CKD In
- 3w agoMLYSMineralys Therapeutics Expands its Board of Directors with the Appointments of Kristine Peterson and Lonnel CoatsGlobeNewswireRADNOR, Pa., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in
- 1mo agoMLYSMineralys Therapeutics Presents New Data for Lorundrostat at the American Heart Association Hypertension Scientific Sessions 2026GlobeNewswire- New analyses from the pivotal Launch-HTN trial showed that 46% of participants with difficult-to-treat hypertension receiving lorundrostat 50 mg achieved the AHA/ACC Guideline systolic blood pressure target of <130
- 1mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Sept. 21, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes
- 2mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes
- 2mo agoMLYSMineralys Therapeutics to Participate in the Wells Fargo 21st Annual Healthcare ConferenceGlobeNewswireRADNOR, Pa., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in
- 3mo agoMLYSMineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in
- 3mo agoMLYSMineralys Therapeutics to Announce Second Quarter 2026 Financial Results and Host Conference Call on Tuesday, August 11, 2026GlobeNewswireRADNOR, Pa., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in
- 3mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., July 27, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes
- 5mo agoMLYSMineralys Therapeutics Presents Late-Breaking Data on Lorundrostat and Heart Failure Risk Biomarkers at The Endocrine Society Annual Meeting (ENDO 2026)GlobeNewswire– Lorundrostat was associated with significant reductions in heart failure risk biomarkers in a proteomic analysis of data from participants with uncontrolled hypertension – – Coordinated reductions in biomarkers of
- 5mo agoMLYSMineralys Therapeutics to Participate in the Goldman Sachs 47th Annual Global Healthcare ConferenceGlobeNewswireRADNOR, Pa., June 08, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 5mo agoMLYSMineralys Therapeutics to Present Late-Breaking Data on Lorundrostat at The Endocrine Society Annual Meeting (ENDO 2026)GlobeNewswireRADNOR, Pa., June 08, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 5mo agoMLYSMineralys Therapeutics Announces Pricing of $150 Million Underwritten Offering of Common StockGlobeNewswireRADNOR, Pa., June 03, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 5mo agoMLYSMineralys Therapeutics Announces Repurchase of Royalty Obligations in Tanabe License Agreement and Concurrent FinancingGlobeNewswire– Repurchase of lorundrostat royalty obligation in Tanabe license agreement for $200 million upfront and up to $100 million once certain commercial milestones are met – – $500 million committed under senior secured term
- 5mo agoMLYSMineralys Therapeutics Presents New Data from the Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Hypertension and Chronic Kidney Disease at European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)GlobeNewswire– Post hoc analysis from pivotal Launch-HTN trial shows statistically significant and clinically meaningful reductions in blood pressure in participants with chronic kidney disease – – In participants with chronic
- 5mo agoMLYSMineralys Therapeutics to Participate in the Jefferies Global Healthcare ConferenceGlobeNewswireRADNOR, Pa., May 27, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 5mo agoMLYSMineralys Therapeutics Announces Presentation of New Data from the Phase 3 Launch-HTN Trial of Lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)GlobeNewswire– Oral presentation highlights efficacy and safety profile of lorundrostat in patients with uncontrolled hypertension and chronic kidney disease – RADNOR, Pa., May 18, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics,
- 6mo agoMLYSMineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate UpdateGlobeNewswire– NDA for lorundrostat in adults with hypertension accepted by FDA; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 06, 2026 (GLOBE NEWSWIRE) -- Mineralys
- 6mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 6mo agoMLYSMineralys Therapeutics to Participate in the Bank of America Securities Health Care ConferenceGlobeNewswireRADNOR, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 6mo agoMLYSMineralys Therapeutics to Announce First Quarter 2026 Financial Results and Host Conference Call on Wednesday, May 6, 2026GlobeNewswireRADNOR, Pa., April 29, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 7mo agoMLYSMineralys Therapeutics Appoints Jeffrey A. Munsie as Chief Legal OfficerGlobeNewswireRADNOR, Pa., March 24, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 8mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., March 16, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 8mo agoMLYSMineralys Therapeutics Reports Fourth Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswire– Announced FDA acceptance of NDA for lorundrostat in adults with hypertension; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., March 12, 2026 (GLOBE
- 8mo agoMLYSMineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial ResultsGlobeNewswire– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with
- 8mo agoMLYSMineralys Therapeutics to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on Thursday, March 12, 2026GlobeNewswireRADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic
- 8mo agoMLYSPROKIRONREGN+5Chronic Kidney Disease Market Poised to Expand Significantly During Forecast Period (2025-2034) as Demand for Early Diagnosis and Novel Therapies Increases | DelveInsightPR NewswireRecently published Chronic Kidney Disease Market Insights report includes a comprehensive understanding of current treatment practices, chronic...
- 8mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 9mo agoMLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 11mo agoMLYSMineralys Therapeutics' Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) "Research of the Year" RoundupGlobeNewswire– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA
- 11mo agoMLYSMineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireRADNOR, Pa., Nov. 26, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 1y agoMLYSMineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswire– Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 – – Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 – – Conference call today at 4:30 p.m. ET
- 1y agoMLYSData for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025GlobeNewswire– Late-breaking presentation of Explore-CKD trial at ASN Kidney Week – – Pivotal Phase 3 Launch-HTN trial featured in the "Best of JAMA and NEJM" session - RADNOR, Pa., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Mineralys
- 1y agoMLYSMineralys Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireRADNOR, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 1y agoMLYSMineralys Therapeutics to Announce Third Quarter 2025 Financial Results and Host Conference Call on Monday, November 10, 2025GlobeNewswireRADNOR, Pa., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 1y agoMLYSMineralys Therapeutics Announces Late-Breaking Presentation of Phase 2 Explore-CKD Trial of Lorundrostat at American Society of Nephrology (ASN) Kidney Week 2025GlobeNewswire~ Late-breaking Phase 2 trial data evaluating the safety and efficacy of 25 mg of lorundrostat in participants with hypertension and comorbid CKD to be presented~~ Phase 3 data of the Launch-HTN Trial of lorundrostat to
- 1y agoMLYSMineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and HypertensionGlobeNewswire~ Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 ~ RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused
- 1y agoMLYSMineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical NeedGlobeNewswire~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~ ~Subgroups - including Black or African American
- 1y agoMLYSMineralys Therapeutics Announces Closing of Upsized $287.5 Million Underwritten Public Offering of Common Stock Including Full Exercise of Underwriters' Option to Purchase Additional SharesGlobeNewswireRADNOR, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 1y agoMLYSMineralys Therapeutics Announces Pricing of Upsized $250.0 Million Underwritten Public Offering of Common StockGlobeNewswireRADNOR, Pa., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities
- 1y agoMLYSMineralys Therapeutics Announces Proposed Public Offering of Common StockGlobeNewswireRADNOR, Pa., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities